Drug class · FAERS comparison

Insulin Analog side effects compared: 10 drugs, 561,793 FDA adverse event reports

Class as assigned in the FDA label (Established Pharmacologic Class) · data 2026-09-14

How to read this page. Report counts are not incidence rates: a drug with more reports is usually older, more widely used or more publicised, not more dangerous. Signals are screened against each product's FDA label on its own page; a term flagged across most of a class usually reflects the shared mechanism or the shared patient population.

Members

Drug	FAERS reports	Serious	Death outcome	Boxed warning	Top labeled signals	Unlabeled (unassessed)
Insulin Glargine (Toujeo)	245,215	52%	13,511	–	Blood glucose increased; Blood glucose decreased; Hypoglycaemia	Accidental underdose; Hypoglycaemic coma
Insulin Lispro (Admelog)	137,346	46%	6,025	–	Blood glucose increased; Blood glucose decreased; Hypoglycaemia	Accidental underdose; Hypoglycaemic unconsciousness
Insulin Aspart (Novolog)	62,953	63%	4,460	–	Blood glucose decreased; Diabetes mellitus inadequate control; Hypoglycaemic unconsciousness	Nephrogenic anaemia; Appendicolith
Insulin (Insulin 1556)	55,432	78%	7,568	–	–	–
Insulin Degludec	23,329	59%	1,281	–	Blood glucose decreased; Diabetes mellitus inadequate control; Hypoglycaemic seizure	Impaired gastric emptying; Appendicitis
Insulin Glargine-Yfgn (Insulin Glargine)	21,736	88%	2,408	–	Hypoglycaemia; Respiratory symptom; Diabetic metabolic decompensation	Pulmonary alveolar haemorrhage; Neurological symptom
Insulin Glulisine (Apidra, Apidra Solostar)	10,109	76%	806	–	Blood glucose increased; Hypoglycaemia; Hyperglycaemia	Hypoglycaemic coma; Intestinal haemorrhage
Insulin Aspart (Novolog)	2,594	64%	138	–	Blood glucose increased; Blood glucose decreased; Diabetic ketoacidosis	Stress; Multiple organ dysfunction syndrome
Insulin Lispro-Aabc (Lyumjev)	2,046	21%	35	–	Blood glucose increased; Infusion site pain; Injection site pain	Haemorrhage; Visual impairment
Diluent (Humalog, Humalog Kwikpen)	1,033	6%	7	–	Injection site erythema; Injection site pruritus; Injection site warmth	Herpes zoster

Class-wide signals (flagged in at least 5 of 10 members)

Reaction	Members flagged	Median PRR	Reports (sum)	In label
Diabetes mellitus inadequate control	8/10	20.8	8,095	7/8 members' labels
Hypoglycaemia	7/10	16.3	16,226	6/7 members' labels
Diabetic retinopathy	6/10	32.4	2,135	4/6 members' labels
Hypoglycaemic coma	6/10	23.0	1,372	0/6 members' labels
Hypoglycaemic unconsciousness	5/10	48.5	1,583	2/5 members' labels
Hypoglycaemic seizure	5/10	37.8	593	3/5 members' labels
Diabetic metabolic decompensation	5/10	32.9	590	3/5 members' labels
Diabetic ketoacidosis	5/10	16.3	3,139	4/5 members' labels
Hyperglycaemia	5/10	12.6	6,608	4/5 members' labels

Member-specific signals (flagged in exactly one drug)

Reaction	Drug	Reports	PRR	Label screen
Eosinophilic granulomatosis with polyangiitis	Insulin Glargine-Yfgn	155	80.2	Not in label — unassessed
Conjunctivitis allergic	Insulin Glargine-Yfgn	105	74.6	Not in label — unassessed
Increased insulin requirement	Insulin Lispro	57	47.9	Likely indication confounding
Blood ketone body	Insulin Lispro	83	47.8	Not in label — unassessed
Ventricular fibrillation	Insulin Aspart	61	44.5	Not in label — unassessed
Intercepted product selection error	Insulin Lispro	273	42.2	Not in label — unassessed
Intercepted drug dispensing error	Insulin Lispro	323	41.5	Not in label — unassessed
Normochromic normocytic anaemia	Insulin Glargine-Yfgn	113	37.7	Not in label — unassessed
Cardiogenic shock	Insulin Aspart	66	37.5	Not in label — unassessed
Pulmonary alveolar haemorrhage	Insulin Glargine-Yfgn	195	34.8	Not in label — unassessed
Neurological symptom	Insulin Glargine-Yfgn	190	33.4	Not in label — unassessed
Nephrogenic anaemia	Insulin Aspart	407	30.4	Not in label — unassessed
Iron deficiency	Insulin Degludec	120	24.9	Not in label — unassessed
Gastrointestinal hypomotility	Insulin Degludec	56	23.1	Not in label — unassessed
Large for dates baby	Insulin	51	23.0	No label text to screen
Diabetic eye disease	Insulin Lispro	59	22.7	Labeled (related wording)
Multiple organ dysfunction syndrome	Insulin Aspart	77	22.4	Not in label — unassessed
Bacterial infection	Insulin Aspart	51	22.2	Not in label — unassessed
Herpes zoster	Diluent	59	20.8	Not in label — unassessed
Neuralgia	Insulin Aspart	56	18.7	Not in label — unassessed
Ascites	Insulin Aspart	66	18.2	Not in label — unassessed
Hypoglycaemia neonatal	Insulin	66	16.2	No label text to screen
Retinopathy	Insulin Lispro	329	14.7	Labeled adverse reaction
Diabetic nephropathy	Insulin	79	14.0	No label text to screen
Ischaemic cardiomyopathy	Insulin	98	12.3	No label text to screen

Common questions

Which insulin analog has the most FDA adverse event reports?

Insulin Glargine has the most FAERS co-reports in this class (245,215), followed by Insulin Lispro (137,346). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.

Which side effects are shared across insulin analog drugs?

Reaction terms flagged in at least half of the 10 members include diabetes mellitus inadequate control, hypoglycaemia, diabetic retinopathy, hypoglycaemic coma, hypoglycaemic unconsciousness. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.

Does a FAERS signal mean the drug causes the reaction?

No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.

Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.